Varenicline for the treatment of cocaine dependence: Phase II

描述(申请人提供)：治疗可卡因依赖的varenicline：II期临床试验。可卡因依赖仍然是一个主要的公共卫生问题，即使在20多年来不断尝试开发有效的行为和药物干预措施来治疗可卡因依赖之后。由于使用可卡因直接产生的健康成本(例如冠状动脉和血管问题)，以及更间接的成本(例如艾滋病、丙型肝炎病毒的传播)，必须继续努力开发有效的治疗方法。为此，这是一项拟议的双盲安慰剂对照临床试验(n=200)，用于治疗可卡因依赖，利用应急管理提高治疗出勤率。在最近完成的一项使用相同设计的试点试验(n=37)中，我们发现随机服用varenicline的受试者显示出可卡因使用的更大减少，以及他们发现可卡因的价值或强化程度的降低(Plebani等人，修订中)。在那项研究中，我们使用了可变的强化时间表来促进高出勤率。这种强化导致了出席率的戏剧性增加，并导致丢失数据的情况比通常困扰此类试验的情况要少得多。由于这些有希望的结果，我们现在寻求在更大的样本中复制这项研究，以便能够更充分地确定varenicline作为可卡因依赖治疗方法的疗效。 公共卫生相关性：可卡因依赖是一个主要的公共卫生问题，几乎没有有效的治疗方法，复发率很高，而且与负面健康后果密切相关。因此，需要对潜在的可卡因依赖药物进行研究。这类研究应该利用行为干预来最大限度地提高治疗出勤率和保留率，以便更好地确定药物疗效，从而减轻可卡因依赖给医疗保健系统和社会带来的负担。

DESCRIPTION (provided by applicant): Varenicline for the treatment of cocaine dependence: A phase II clinical trial. Cocaine dependence remains a major public health problem, even after over two decades of steady attempts to develop effective behavioral and pharmacological interventions for treating cocaine dependence. Due to the health costs that come directly from cocaine use (e.g., coronary and vascular problems), and those that are more indirect (e.g., spread of AIDS, HCV from exchanging sex for drugs), it is imperative that efforts to develop efficacious treatments continue. To that end, this is a proposed double-blind placebo-controlled clinical trial (n = 200) of varenicline for the treatment of cocaine dependence that utilizes contingency management to promote treatment attendance. In a recently completed pilot trial (n = 37) using the same design, we found that subjects randomized to varenicline showed greater decreases in cocaine use as well as reductions in how valuable or reinforcing they found cocaine (Plebani et al., revision under review). In that study, we used a variable schedule of reinforcement to promote high rates of attendance. That reinforcement led to dramatic increases in attendance rates, and led to far less missing data than usually plagues such trials. Due to these promising results, we now seek to replicate that study in a larger sample in order to have the power to more fully determine the efficacy of varenicline as a treatment for cocaine dependence. PUBLIC HEALTH RELEVANCE: Cocaine dependence is a major public health problem, with few effective treatments, high relapse rates, and a strong association with negative health consequences. As such, research examining potential cocaine dependence medications is needed. Such research should utilize behavioral intervention to maximize treatment attendance and retention in order to better determine medication efficacy, and thus decrease the burden that cocaine dependence places on the healthcare system and on society.